Acute Lymphoblastic Leukemia and B-Lineage Lymphoma Treatment via Risk-Adapted Chemotherapy – Phase III

Risk-Adapted Chemotherapy in Treating Younger Patients with Newly Diagnosed Standard-Risk B-Acute Lymphoblastic Leukemia or localized B-Lineage Lymphoblastic Lymphoma

Protocol Description

This multicenter trial by the Children’s Oncology Group studies different combinations of risk-adapted chemotherapy regimens and their side effects, comparing how well they work in treating younger patients with newly diagnosed standard-risk B acute lymphoblastic leukemia (B-ALL) or patients with B-lineage lymphoblastic lymphoma (B-LLy) that is found only in the tissue or organ where it began (localized).

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to males and females, ages 1 to 10 years, who have newly diagnosed B-ALL and are already enrolled in COG AALL08B1, or patients with B-LLy ages 1 to 30.
Males and Females: Ages 1 to 30 years

Requirements

Study participants will receive standard “induction” chemotherapy at the initial stage of this study followed by testing to determine their risk level. Participants with high-risk conditions will be assigned to one of four maintenance therapy treatment groups, each which takes the same combination of five drugs administered over 12-week courses, but with dosage levels for specific drugs calibrated at different levels as specified in the protocol. Participants with low-risk conditions will be randomly assigned to one of two treatment arms, each with a different chemotherapy regimen. Courses cycles repeat for to 2 to 3 years.
Visits: Varies from daily to weekly to monthly depending on the treatment arm and stage of treatment.
Duration: 2 to 3 years for therapy, with patients followed for up to 10 years from the time of enrollment.

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (AALL0932)
National Cancer Institute

Primary Investigator

Kim Ritchey, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinator Angela Connelly, RN, BSN
412-692-8864